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Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries

Sponsor
Koç University (Other)
Overall Status
Completed
CT.gov ID
NCT05061667
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
11.4
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main aim of this study is to compare thoracic paravertebral block and rhomboid block for postoperative analgesia and analgesic usage in thoracic surgeries.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thoracic Paravertebral Block
  • Procedure: Rhomboid Block
 N/A

Detailed Description

Patients with scheduled thoracic surgery are going to be enrolled for this study. Patients will be randomized and separated in two groups. Group I will receive thoracic paravertebral block, group II will receive rhomboid block. Each group will receive patient controlled analgesia with intravenous fentanyl. Patients will be monitored at postoperative 1st, 3rd, 6th, 12th, 24th hours and their VAS scores, adverse reactions like nausea and vomiting, total analgesic usage, additional analgesic need and time of the first report of pain will be filed. Then the two groups will be compared and evaluated.

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I

Group I will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve paravertebral block which is already proven to be effective in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, paravertebral block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the paravertebral space at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).

Procedure: Thoracic Paravertebral Block
Paravertebral block for postoperative analgesia in thoracic surgery
Other Names:
  • TPVB

    		•
    Experimental: Group II

    Group II will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve rhomboid block which is being experimented for its efficacy in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, rhomboid block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the plane between rhomboid muscle and intercostal muscles, medial to scapula at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).

    Procedure: Rhomboid Block
    Rhomboid block for postoperative analgesia in thoracic surgery

    Outcome Measures

    Primary Outcome Measures

    1. Difference in Visual Analogue Scale (VAS) scores between two groups [24 hours]

      Statistically significant difference in VAS scores at 1st, 3rd, 6th, 12th, 24th hours between two groups. On a scale of 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.

    2. Difference in additional analgesic usage between two groups [24 hours]

      Intravenous patient controlled analgesia usage and additional analgesic dosages will be filed as miligrams or micrograms at 1st, 3rd, 6th, 12th, 24th hours.

    Secondary Outcome Measures

    1. Incidence of nausea and vomiting [24 hours]

      Incidence of symptoms like nausea and vomiting will be filed at 1st, 3rd, 6th, 12th, 24th hours. On a scale of 0 to 1, where 0 means no symptoms and 1 means nausea and vomiting.

    2. Patient satisfaction [24 hours]

      Patient will be reevaluated at 24th hour for analgesic satisfaction. On a scale of 0 to 3, where 0 means not satisfied and 3 means satisfied.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients scheduled for general thoracic surgery

    • ASA I-III

    Exclusion Criteria:

    • Patients without consent

    • Emergency surgeries

    • Pregnancy

    • Coagulopathies and bleeding diathesis

    • Allergy to local anesthetics

    • Local skin infection at the puncture site

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Koç University Istanbul Turkey 34010

    Sponsors and Collaborators

    • Koç University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Koç University
    ClinicalTrials.gov Identifier:
    NCT05061667
    Other Study ID Numbers:
    • 2021.066.IRB1.022
    First Posted:
    Sep 29, 2021
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Koç University
    Thoracic surgery
    Postoperative pain
    Rhomboid block
    Paravertebral block
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Jan 20, 2022